| NCT ID | NCT02098252 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) |
| Condition | Unruptured Brain Arteriovenous Malformation |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2014-05 |
| Primary Completion | 2035-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2014-05 with a primary completion date of 2035-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
Eligibility Criteria
Inclusion Criteria: * Any patient with a brain AVM Exclusion Criteria: * Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS.
Contact & Investigator
Daniel Roy, MD
PRINCIPAL INVESTIGATOR
CHUM-Montreal
Frequently Asked Questions
Who can join the NCT02098252 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Unruptured Brain Arteriovenous Malformation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02098252 currently recruiting?
Yes, NCT02098252 is actively recruiting participants. Contact the research team at daniel.roy.chum@ssss.gouv.qc.ca for enrollment information.
Where is the NCT02098252 trial being conducted?
This trial is being conducted at Jacksonville, United States, Boston, United States, Albuquerque, United States, Fortaleza, Brazil and 11 additional locations.
Who is sponsoring the NCT02098252 clinical trial?
NCT02098252 is sponsored by Centre hospitalier de l'Université de Montréal (CHUM). The principal investigator is Daniel Roy, MD at CHUM-Montreal. The trial plans to enroll 1,000 participants.